Clinical Affairs Project Manager||臨床開発プロジェクト・マネージャー

Company Overview: Company develops medical technology in following areas: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. Product portfolio includes implantable cardioverter defibrillators, pacemakers, electrophysiology catheters, mapping and visualization systems, products for structural heart and vascular diseases, and spinal cord stimulation devices.

Job Contents:




Provides leadership for a particular clinical project. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of medical products. Manages clinical project teams to appropriate and timely completion of projects;oversees project timeline development and maintenance. Interfaces with data management and biostatistics, field monitors, medical doctors, functional management, and acts as liaison with investigators and clinical site staff. Works under the direction of management on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

・Responsible and accountable for one or more concurrent clinical studies

・Leverages resources, expertise, and knowledge across projects.

・Participates in an assists in the development and approval of global clinical strategies in collaboration with regulatory affairs, marketing, research&development and outcomes planning.

・Supports regulatory/clinical strategies as one of the clinical representatives for the therapeutic area.

・Prepares and manages budgets for assigned clinical projects.

・Negotiates contracts and budgets with sites and vendors for approval by senior management.

・Reviews protocols for projects before submission for approval; reviews study conduct documents such as study manuals, study tools etc.

・Prepares investinational site lists and participates in reviewing and approving investigational sites.

・Drafts, reviews, and submits for approval instructions for use for investigational devices.

・Manages the coordination of and attends investigator and coordinator meetings, representing the therapeutic area.

・Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse event are identified and appropriate responses to such concerns are developed and executed.

・Provides advice on the reponrtability of adverse events and other clinical trial issues to regulatory agencies.

・Manages data release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript of final reports for projects.

・Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.

・Provides clinical support in working with Pharmaceutical Medical Devices Agency, including Shonin submissions using domestic/foreign clinical data, responses to PMDA questions, and preparation and presentation at PMDA meetings.

・Reviews and approves corrective action plans and individual sites and across study. May participate in internal/exernal study-related audits.


Requirements:



Bachelor degree, degree in science/health related field preferred
5-7 years in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus 1-3 years' experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.

English written/reading skills required and English communication skill strongly preferred.

日本東京 地図

担当者名：